Galantamine Effects on Cognitive Function in Abstinent Cocaine Users

• ClinicalTrials.gov Identifier: NCT00606801
• Recruitment Status: Completed
• First Posted: February 5, 2008
• Results First Posted: July 31, 2013
• Last Update Posted: July 31, 2013
• Sponsor: Yale University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Mehmet Sofuoglu, Yale University

Study Description

Brief Summary:

To evaluate galantamine's effects on cognitive performance in abstinent cocaine users. Galantamine, a medication approved for treatment of Alzheimer's disease, is an acetylcholine esterase inhibitor. Galantamine also directly potentiates nicotine receptors. Both of these effects may result in improved cognitive performance in a group of subjects known to have impaired performance in various cognitive tasks.

Condition or disease	Intervention/treatment	Phase
Cocaine Abuse	Drug: Galantamine; Drug: placebo	Not Applicable

Detailed Description:

Galantamine, compared to placebo, will improve cognitive performance in abstinent cocaine users. The cognitive performance will be measured with the Stroop test and 3 Cambridge Neuropsychological Test Automated Battery (CANTAB) tests: Paired Associate Learning (PAL), Delayed Pattern Recognition Memory (PRM),and Rapid Visual Information Processing (RVIP). Performance on these tests has been shown to be impaired in abstinent cocaine users, compared to healthy controls.

Galantamine, compared to placebo, will not be associated with any significant changes in mood. Monitoring of mood will be achieved with 3 mood scales: 1) Center for Epidemiologic Studies Depression (CES-D) scale, Positive and Negative Affect Schedule (PANAS) and the Profile of Mood States (POMS).

Currently this study is completed, Patients are no longer being enrolled. There were 28 completers. This study has been published.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Galantamine Effects on Cognitive Function in Abstinent Cocaine Users
• Study Start Date: June 2007
• Actual Primary Completion Date: February 2009
• Actual Study Completion Date: February 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Galantamine 8 mg/day; Galantamine 8 mg/day	Drug: Galantamine; Galantamine 8 mg/day; Other Names: Nivalin,; Razadyne,; Razadyne ER,; Reminyl,; Lycoremine
Placebo Comparator: Placebo; placebo	Drug: placebo; sugar pill; Other Name: Sugar Pill

Outcome Measures

Primary Outcome Measures :

1. Performance on 3 Cognitive Tests From the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP, PAL and PRM. [ Time Frame: Baseline, Day 5 and Day 10 ]
   Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. Reaction time (RT) to correct answers, total hits, correct rejections and A' (sensitivity to target sequences) were determined. Paired Associate Learning (PAL) measures visual memory and new learning by testing a the ability to remember the initial location of a pattern after it is re-presented in the middle of the screen. Errors result in a reminder presentation of the original location. The stages completed and number of errors are measures of interest. Pattern Recognition Memory (PRM) tests visual pattern recognition memory in a two choice forced discrimination paradigm. 12 visual patterns are presented, then the subject must choose between each of these patterns and a novel pattern.

Secondary Outcome Measures :

1. Performance on the Sustained Attention to Response Task (SART). [ Time Frame: Baseline, Day 5 and Day 10 ]

   The SART is a Go / NoGo task measuring the ability to activate or inhibit responses. Cocaine users are know to have deficits in response inhibition on such tasks. The number of errors on NoGo and Go trials, as well as the mean reaction time (RT in milliseconds) for correct responses on Go Trials were measured.

   Complete data for 3 subjects in the Placebo group, and for 1 subject in the galantamine group were not capture do to experimenter and computer errors.

2. Performance on the Modified Stroop Task (Cocaine-Stroop) [ Time Frame: Baseline, Day 5 and Day 10 ]
   The Cocaine-Stroop task measures attention capture (attentional bias) secondary to cocaine cues; (Stroop effect - calculated as the difference between mean RT on cocaine words and mean RT on control words). Subjects completed 2 counterbalanced blocks (150 trials per block). One block contained 15 cocaine words and neutral words in a mixed order. The other block contained 15 control words matched in length and frequency to cocaine words, and a different set of neutral words. Subjects were required to indicate the colors in which the words were written as quickly and accurately as possible. Reaction times for identification of word color was measured. In addition, the difference in RT to words following cocaine and control words were measured (carry-over effect). Complete data for 3 participants (2 placebo and 1 galantamine) were not capture due to experimenter and computer errors.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male and females, between the ages 21 and 50
• Fulfill criteria for past cocaine dependence
• No cocaine use for the past 30 days
• No other current dependence or abuse of other drugs or alcohol
• No current medical problems and normal ECG
• Not pregnant,nor breast feeding,
• Using acceptable birth control methods.

Exclusion Criteria:

• Current major psychiatric illness including mood, psychotic or anxiety disorders
• History of major medical illnesses; including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances
• Use of other medications including,drugs that slow heart rate
• Known allergy to galantamine

Contacts and Locations

Locations

United States, Connecticut

Veterans Affairs Hospital

West Haven, Connecticut, United States, 06516

Sponsors and Collaborators

Yale University

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D.; Yale University Associate Professor

More Information

• Responsible Party: Mehmet Sofuoglu, Principle Investigator, Yale University
• ClinicalTrials.gov Identifier: NCT00606801
• Other Study ID Numbers: HIC # 0706002768; P50DA009241 ( U.S. NIH Grant/Contract ); B Rounsaville ( Other Identifier: Principal Investigator of P50 grant )
• First Posted: February 5, 2008
• Results First Posted: July 31, 2013
• Last Update Posted: July 31, 2013
• Last Verified: February 2012

Keywords provided by Mehmet Sofuoglu, Yale University:

cognitive enhancers; Nootropic Agents

Additional relevant MeSH terms:

Cocaine-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Galantamine; Cholinesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Parasympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Nootropic Agents